On February 13, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that details relating to the release of its fourth quarter and full year 2019 financial results (Press release, ViewRay, FEB 13, 2020, View Source [SID1234554323]).

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ViewRay will hold a conference call to discuss results on Thursday, March 12, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525 -7129 for international callers. The conference ID number is 6095383. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until March 19, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 6095383.

On February 13, 2020 Luminex Corporation (NASDAQ: LMNX) reported that Homi Shamir, President & CEO, and Harriss Currie, Senior Vice President of Finance and CFO, plan to participate at three investor conferences in March 2020 (Press release, Luminex, FEB 13, 2020, View Source [SID1234554322]).

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Morgan Stanley European MedTech & Services Conference in London, England on March 3, 2020: one-on-one investor meetings. Webcasts are not available for this Morgan Stanley event.
Barclays Global Healthcare Conference in Miami, Florida on March 11, 2020: one-on-one investor meetings and live webcast of "fireside chat" with an analyst and investors on March 11 at 10:45 a.m. to 11:10am Eastern Time. The webcast may be accessed at Luminex’s website at investor.luminexcorp.com. The session will be archived for six months on the website using the ‘replay’ link.
BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah on March 19, 2020: one-on-one investor meetings. Webcasts are not available for this BTIG event.

On February 13, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, CryoLife, FEB 13, 2020, View Source [SID1234554321]).

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"The fourth quarter was marked by significant progress on our key initiatives, highlighted by European approvals for two next generation JOTEC products, E-nside and E-nya, the approval to commence the PROACT Xa trial to study the use of Eliquis with the On-X Aortic Valve, the initial launch of NEXUS into select European markets, as well as our collaboration with Misonix," said Pat Mackin, Chairman, President, and Chief Executive Officer. "Additionally, we anticipate the approval for E-vita OPEN NEO in the first quarter of 2020, and we continue to increase JOTEC and vascular tissue supply. The full launch in 2020 of three next generation JOTEC products and NEXUS, as well as the commencement of the PROACT Xa trial, positions us well to deliver high single-digit revenue growth over the next several years."

Fourth Quarter 2019 Financial Results
Total revenues for the fourth quarter of 2019 were $69.7 million, reflecting growth of 3%, and 4% on a non-GAAP constant currency basis, both compared to the fourth quarter of 2018. The non-GAAP constant currency increase was driven by revenue growth from On-X, tissue processing, and JOTEC, excluding JOTEC OEM.

Net loss for the fourth quarter of 2019 was ($681,000), or ($0.02) per fully diluted common share, compared to a net loss of ($776,000), or ($0.02) per fully diluted common share for the fourth quarter of 2018. Non-GAAP net income for the fourth quarter of 2019 was $3.8 million, or $0.10 per fully diluted common share, compared to non-GAAP net income of $1.9 million, or $0.05 per fully diluted common share for the fourth quarter of 2018.

Full Year 2019 Financial Results
Total revenues for 2019 were $276.2 million, reflecting growth of 5% on a reported basis and 7% on a non-GAAP constant currency basis compared to 2018. The increase was driven by growth in the On-X, BioGlue and JOTEC product lines as well as the tissue processing business. For 2019, On-X and JOTEC non-GAAP constant currency revenues increased by 12% and 9%, respectively, versus 2018.

Net income for 2019 was $1.7 million or $0.05 per share compared to a net loss of ($2.8) million or ($0.08) per share for 2018. Non-GAAP net income for 2019 was $11.7 million, or $0.31 a share compared to non-GAAP net income of $9.6 million, or $0.26 per share in 2018.

The independent registered public accounting firm’s audit report with respect to the Company’s fiscal year-end financial statements will not be issued until the Company completes its annual report on Form 10-K, including its evaluation of the effectiveness of internal controls over financial reporting. Accordingly, the financial results reported in this earnings release are preliminary pending completion of the audit.

2020 Financial Outlook
CryoLife expects constant currency revenue growth of between 6.3% and 8.5% for the full year of 2020 compared to 2019. Assuming a Euro/USD exchange rate of 1.10, revenues are expected to be in the range of $292 million to $298 million. Our 2020 revenue guidance assumes no contribution during 2020 from BioGlue in China, PerClot in the U.S., or TMR handpieces.

Non-GAAP earnings per share for 2020 are expected to be between $0.15 and $0.17. Non-GAAP earnings per share reflect approximately $0.12 per share in planned incremental investment in the Company’s pipeline, an estimated $0.06 per share additional investment in our Asia Pacific and Latin American infrastructure, and approximately $0.05 per share in planned incremental spending related to new product launches.

All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

The Company’s financial guidance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company’s non-GAAP net income and non-GAAP EBITDA results exclude (as applicable) business development and integration expenses, rebranding expenses, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, and stock-based compensation expense. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating items; the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, February 13, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through February 20, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13698400.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

On February 13, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare total talent solutions, reported its fourth quarter and full year 2019 financial results (Press release, AMN Healthcare Services, FEB 13, 2020, View Source [SID1234554320]). Financial highlights are as follows:

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Dollars in millions, except per share amounts.

* See "Non-GAAP Measures" below for a discussion of our use of non-GAAP items and the table entitled "Non-GAAP Reconciliation Tables" for a reconciliation of non-GAAP items.

2019 & Recent Highlights

Fourth quarter results exceeded expectations, with the Nurse and Allied Solutions segment delivering higher revenue from the support of labor disruption events and rapid response staffing
Nurse and Allied segment recorded 6% year-over-year organic growth in the fourth quarter
Full year operating cash flow was $225 million, reflecting strong performance and a nine-day reduction in days’ sales outstanding
Acquired b4health, an innovative float pool management technology solution and vendor management system, in December
The previously announced acquisition of Stratus Video, the leading provider of healthcare video remote language interpretation services, is expected to close on February 14, 2020
The Stratus acquisition is expected to be immediately margin-accretive and strengthens AMN’s position as healthcare’s leading total talent solutions partner
"Throughout the last year and decade, AMN Healthcare achieved many important milestones and dramatically enhanced our ability to positively impact patient care and our communities," said Susan R. Salka, Chief Executive Officer of AMN. "During 2019, our business reached new highs in revenue and earnings, while also making critical investments in our people, processes and solutions for our healthcare professionals and clients. AMN furthered our ability to serve our clients’ total talent needs with the acquisition of Advanced Medical, Silversheet and b4health, along with the imminent acquisition of Stratus Video.

"As we enter 2020, demand for our services remains strong, and we are excited about the partnerships we are building with clients to address their workforce challenges and ensure they deliver high-quality patient care. Equally critical to our purpose at AMN, we will continue to take an active leadership role in governance and social issues such as diversity, equality and inclusion," Ms. Salka added.

Fourth Quarter 2019 Results

Consolidated revenue for the quarter was $587 million, an 11% increase over prior year and 3% higher than prior quarter. Revenue for the Nurse and Allied Solutions segment was $389 million, up 18% year over year (6% organic) and 7% sequentially. Travel Nurse revenue increased 9% year over year (2% organic). Allied division revenue increased 45% year over year with 7% organic growth.

The Locum Tenens Solutions segment reported revenue of $78 million, down by 5% year over year due to slightly lower volume and a mix shift to specialties with lower bill rates. Volume metrics were on par with prior year in December, which we believe reflects stability and future growth opportunity as we enter the new year. Other Workforce Solutions segment revenue was $120 million reflecting an increase of 2% year over year, driven primarily by growth in our physician permanent placement, interim leadership and VMS businesses, offset partly by a decline in our revenue cycle solutions division.

Gross margin was 33.6%, higher by 100 basis points year over year and higher by 10 basis points sequentially. The year-over-year variance stemmed from an increase in higher-margin labor disruption activities in our Nurse and Allied segment and a favorable mix shift in our Other Workforce Solutions segment.

SG&A expenses were $133 million or 22.7% of revenue, compared with $111 million, or 21.0% of revenue, in the same quarter last year. SG&A was $133 million, or 23.5% of revenue, in the previous quarter. Higher SG&A expenses from our acquired businesses coupled with higher acquisition and integration-related costs caused the year-over-year increase in expense margin.

Income from operations was $47 million, or 8.0% of revenue, compared with $50 million, or 9.5% of revenue, in the same quarter last year. Adjusted EBITDA was $75 million, with a year-over-year increase of 14%. Adjusted EBITDA margin was 12.9%, higher by 30 basis points year over year and an increase of 70 basis points sequentially. The higher-than-expected adjusted EBITDA margin was driven primarily by the higher labor disruption revenue.

Net income was $27 million, or $0.58 per diluted share, compared with $36 million, or $0.74 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.85.

Full Year 2019 Results

Full year 2019 consolidated revenue was $2,222 million, a 4% increase from prior year. Nurse and Allied Solutions segment revenue was $1,420 million, a year-over-year increase of 9%. The Locum Tenens Solutions segment recorded revenue of $325 million, down by 17% compared with the prior year. Other Workforce Solutions segment revenue was $477 million, 9% higher year over year.

Full year gross margin was 33.5% compared with 32.6% for the prior year. The gross margin for the year was positively impacted by higher-than-average gross margins in our Nurse and Allied Solutions segment and a favorable segment mix shift. These positive factors were partially offset by a lower margin in our Locum Tenens Solutions segment.

Full year SG&A expenses were $508 million, representing 22.9% of revenue as compared to $452 million, representing 21.2% of revenue, for the prior year. The year-over-year increase in SG&A expenses was primarily due to additional expenses from the acquired businesses, a $22 million increase related to acquisition, integration, changes in the fair value of earn-out liabilities from acquisitions and extraordinary legal expenses, and a $5 million increase in share-based compensation expense. The increase was partially offset by a $12 million increase in legal reserves in 2018.

Full year income from operations was $177 million, or 8.0% of revenue, compared with $203 million, or 9.5% of revenue, in the prior year. Adjusted EBITDA was $277 million, a year-over-year increase of 3%. Adjusted EBITDA margin was 12.5%, representing a decrease of 20 basis points year over year.

Full year net income was $114 million, or $2.40 per diluted share, compared with $142 million, or $2.91 per diluted share, in the prior year. Adjusted diluted EPS was $3.18.

At December 31, 2019 cash and cash equivalents totaled $83 million. Cash flow from operations was $79 million for the quarter and $225 million for the full year. Capital expenditures were $10 million in the quarter and $35 million for the year. The Company ended the year with total debt outstanding of $625 million with a leverage ratio of 2.0 to 1 as calculated in accordance with the Company’s credit agreement.

Stratus Video Acquisition

In January 2020, AMN signed a definitive agreement to acquire Stratus Video, the largest healthcare remote video language interpretation company. Qualified healthcare interpretation, which is mandated by federal and many state regulations, is a service that many healthcare organizations do not have the resources to provide for themselves. AMN received regulatory approval for the acquisition, which is expected to close tomorrow. The purchase price for the transaction is $475 million and will be funded with borrowings under our credit facility and cash on hand.

"Stratus Video is a compelling addition to the AMN total talent solutions strategy and a wonderful opportunity to strengthen and diversify our leadership and broader talent team," said Ms. Salka. "Stratus is the clear leader in the fastest-growing segment of the language interpretation market for healthcare. They bring a highly regarded service to a growing and important patient population, and Stratus also brings an attractive financial profile."

First Quarter 2020 Outlook

*Note: Guidance percentage metrics are approximate. For a reconciliation of adjusted EBITDA margin, see the table entitled "Reconciliation of Guidance Operating Margin to Guidance Adjusted EBITDA Margin" below.

Projected year-over-year revenue growth in the first quarter of 2020 is 12-14%. On an organic basis, revenue is projected to increase 2-3%. Nurse and Allied segment revenue is expected to be up by 14-16% compared with prior year, with organic growth of 2-4%. Locum Tenens revenue in the first quarter is expected to be flat to up 1% compared with prior year. Stratus Video revenue is expected to be approximately $15 million reflecting anticipated results from the date of acquisition. Guidance assumes no labor disruption revenue in the quarter.

Conference Call on February 13, 2020

AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in total talent solutions, will host a conference call to discuss its fourth quarter and full year 2019 financial results and first quarter 2020 outlook on Thursday, February 13, 2020, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (844) 721-7241 in the U.S. or (409) 207-6955 internationally. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 6:30 p.m. Pacific Time on February 13, 2020, and can be accessed until 11:59 p.m. Eastern Time on February 27, 2020, by calling (866) 207-1041 in the U.S. or (402) 970-0847 internationally, with access code 2857669.

On February 13, 2020 VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet medical need, reported financial results for its fiscal year 2020 third quarter ended December 31, 2019 (Press release, VistaGen Therapeutics, FEB 13, 2020, View Source [SID1234554319]).

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VistaGen has a multi-asset, clinical-stage CNS pipeline, including three differentiated drug candidates, two of which, PH94B and PH10, have positive human clinical data in individuals with social anxiety disorder (SAD) and major depressive disorder (MDD), respectively, and one of which, PH94B, is in preparation to advance into Phase 3 clinical development for the treatment of SAD by the end of this calendar year. Each of VistaGen’s CNS product candidates has an exceptional safety profile, potential for rapid-onset therapeutic benefits, and multiple shots on goal in CNS markets where current treatments are inadequate, resulting in high unmet medical need.

Recent CNS Pipeline Updates:

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of VistaGen’s most advanced drug candidate, PH94B neuroactive nasal spray for on-demand treatment of SAD, the first such designation granted by the FDA for development of a drug candidate for SAD.
VistaGen’s Investigational New Drug (IND) application for AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) antagonist prodrug, as a potential new treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa therapy, has been cleared by the FDA, permitting VistaGen to proceed with Phase 2a clinical development of AV-101 in this indication.
The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. The patent, once issued, will be in effect until at least 2034.
VistaGen announced successful results from an AV-101 first-step, Phase 1b clinical study with healthy U.S. military Veterans, which measured NMDAR target engagement of AV-101 for potential treatment of suicidal ideation in Veterans. The findings from the study were presented in a poster, titled "Evoked and Resting State Gamma Mechanics to Test NMDA Receptor Engagement of Kynurenine Pathway Modulator AV-101 in Healthy Veterans," at the 2019 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) on December 11, 2019.
VistaGen announced positive preclinical data of AV-101 administered in combination with probenecid demonstrating substantially increased brain concentration effects of AV-101 and its active metabolite, 7-Cl-KYNA. When given together with AV-101, probenecid increased brain concentrations of AV-101 7-fold and its active metabolite, 7-CI-KYNA, 35-fold. The resulting increased brain levels and duration of 7-Cl-KYNA suggest the potential impact of AV-101 with probenecid could result in far more profound therapeutic benefits for patients with MDD than in prior clinical studies that did not involve probenecid, as well as in other NMDAR-focused CNS diseases and disorders. Results on AV-101 transport with adjunctive probenecid were presented by a collaborator of VistaGen at the British Pharmacological Society’s Pharmacology 2019 annual conference in Edinburgh, UK, on December 17, 2019.
"During the quarter, we made significant progress across our CNS pipeline, including milestones necessary to advance PH94B, our first-in-class, rapid-onset neuroactive nasal spray, into Phase 3 clinical development for treatment of social anxiety disorder later this year," stated Shawn Singh, Chief Executive Officer of VistaGen. "Social anxiety disorder, or SAD, affects as many as 20 million American adults and adolescents and is the third most common mental health disorder in the U.S. With the alarming prevalence of depression, anxiety, and suicide, driven increasingly by excessive use of social media, and staggering increases in dependency, addiction and even deaths associated with misuse and overuse of benzodiazepines, the urgency for a differentiated, fast-acting, non-addictive, non-sedating treatment for SAD and other anxiety-related disorders is more important now than ever before."

Mr. Singh continued, "During the quarter, we were very pleased that PH94B received the FDA’s first ever Fast Track designation for development of a drug candidate for treatment of SAD. We look forward to further advancing our ongoing efforts to meet the needs of millions of individuals with SAD for whom current treatments fall short, while in parallel advancing development of our other first-in-class neuroactive nasal spray, PH10, for major depressive disorder, and our oral prodrug, AV-101, for treatment of CNS indications involving the NMDA receptor."

Financial Results for the Fiscal Quarter Ended December 31, 2019:

Net loss attributable to common stockholders for the fiscal quarter ended December 31, 2019 decreased to approximately $6.3 million compared to $7.5 million for the fiscal quarter ended December 31, 2018, primarily resulting from the $2.0 million noncash expense associated with the stock-based acquisition of the license to develop and commercialize PH10 in the 2018 quarter.

Research and development expense decreased to $3.0 million for the fiscal quarter ended December 31, 2019, compared with $5.3 million for the fiscal quarter ended December 31, 2018, primarily due to the 2018 noncash expense associated with the acquisition of the PH10 license. Expenses related to the Elevate study of AV-101 in MDD and other AV-101 related nonclinical activities decreased in the quarter ended December 31, 2019 compared to 2018, as the Elevate study reached its conclusion following final patient dosing in September 2019. Increased spending for nonclinical activities, including manufacturing expense for PH94B and PH10, generally offset the reduction in AV-101 expenses. In addition to the noncash PH10 license acquisition in the quarter ended December 31, 2018, other noncash expenses, primarily stock-based compensation and depreciation, accounted for approximately $503,000 and $297,000 in the quarters ended December 31, 2019 and 2018, respectively.

General and administrative expense increased to approximately $2.9 million in the fiscal quarter ended December 31, 2019, compared to approximately $1.9 million in the fiscal quarter ended December 31, 2018. Noncash general and administrative expense, $2.0 million in the quarter ended December 31, 2019, increased from $597,000 in the quarter ended December 31, 2018 primarily due to increased noncash stock-based compensation and noncash warrant modification expenses offset by decreased noncash investor and public relations expenses.

At December 31, 2019, VistaGen had cash and cash equivalents of $1.1 million, compared to $13.1 million at March 31, 2019. Subsequent to December 31, 2019, on January 24, 2020, the Company received $2.75 million in gross proceeds from its successful self-placed registered direct offering of common stock and concurrent private placement of warrants.

As of February 12, 2020, there were 47,963,042 shares of common stock outstanding.

VistaGen’s Clinical-Stage CNS Pipeline

VistaGen is developing three new generation clinical-stage CNS drug candidates, PH94B, PH10, and AV-101, each with a differentiated mechanism of action, an exceptional safety profile in all clinical studies to date, and therapeutic potential in multiple CNS markets where current treatments are inadequate to meet high unmet patient needs.

PH94B is an investigational first-in-class, odorless, fast-acting synthetic neurosteroid with therapeutic potential in a wide range of neuropsychiatric indications involving anxiety or phobia. VistaGen is initially developing PH94B as a potential fast-acting, non-sedating, non-addictive new generation treatment of social anxiety disorder (SAD). Upon easy self-administration, a non-systemic microgram-level dose PH94B sprayed into the nose binds to nasal chemosensory receptors that activate neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. Following successfully completed Phase 2 development for SAD, VistaGen is now preparing for Phase 3 clinical development of PH94B for SAD. The FDA has granted Fast Track designation for development of PH94B for treatment of SAD, the FDA’s first ever Fast Track designation for development of a drug candidate for treatment of SAD.

PH10 is an investigational first-in-class, odorless, fast-acting synthetic neurosteroid with therapeutic potential in a wide range of neuropsychiatric indications involving depression and suicidal ideation. VistaGen is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive new generation treatment of major depressive disorder (MDD) that can be conveniently self-administered at home. Upon self-administration, a non-systemic microgram-level dose of PH10 sprayed into the nose binds to nasal chemosensory receptors that, in turn, activate neural circuits in the brain that lead to rapid-onset antidepressant effects, without side effects, systemic exposure or safety concerns that may be caused by FDA-approved drug treatments for MDD, including oral antidepressants and esketamine. Following successfully completed Phase 2a development for MDD, VistaGen is now preparing for planned Phase 2b clinical development of PH10 for MDD.

AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR. Unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all studies to date, AV-101 has exhibited no dissociative or hallucinogenic psychological side effects or safety concerns similar to those that may be caused by drugs such as amantadine, esketamine and ketamine. With its exceptionally few side effects and excellent safety profile, AV-101 has potential to be an oral new generation treatment for multiple large-market CNS indications where current treatments are inadequate to meet high unmet patient needs. Following positive preclinical efficacy studies of AV-101 in multiple CNS indications, as well as recent positive preclinical studies of AV-101 in combination with probenecid, VistaGen is conducting additional AV-101 preclinical studies and assessing opportunities for potential Phase 2a clinical development of AV-101. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.